Official Title: “A Phase 2, 26 Week, Multicentre, Randomized Double Blind, Placebo-Controlled, Crossover Study Evaluating the Efficacy and Safety of Tolterodine, Pregabalin and a Tolterodine-Pregabalin Combination for Idiopathic Overactive Bladder”

Tolterodine is approved for use in the treatment of overactive bladder (OAB). The study is designed to a investigate whether pregabalin may have efficacy in OAB and whether the efficacy is altered when it is combined with tolterodine.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Crossover Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Tolterodine & Pregabalin
  • Tolterodine SR Oral, 2mg, once daily for 4 weeks Pregabalin, Oral, 75 mg, twice daily for 4 weeks
• Drug: Tolterodine
  • Tolterodine SR, Oral, 4 mg, once daily for 4 weeks
• Drug: Placebo
  • Placebo, Oral, twice daily for 4 weeks
• Drug: Tolterodine & Pregabalin
  • Tolterodine SR Oral, 4mg, once daily for 4 weeks Pregabalin, Oral, 150 mg, twice daily for 4 weeks
• Drug: Pregabalin
  • Pregabalin, Oral, 150 mg twice daily for 4 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Tolterodine SR 2 mg once daily combined with pregabalin 75 mg twice daily
• Active Comparator: B
  • Tolterodine SR 4 mg once daily
• Placebo Comparator: C
  • Placebo
• Experimental: D
  • Tolterodine SR 4 mg once daily combined with pregabalin 150 mg twice daily
• Experimental: E
  • Pregabalin 150 mg twice daily

Primary Measures

• Change in mean voided volume per micturition (from baseline).
  • Time Frame: 4 weeks
    Safety Issue?: No

Secondary Measures

• Percentage and absolute change in incontinence episode frequency after 4 weeks of treatment (for subjects with incontinence at baseline).
  • Time Frame: 4 Weeks
    Safety Issue?: No
• Percentage and absolute change in urgency episode frequency
  • Time Frame: 4 Weeks
    Safety Issue?: No
• Mean severity of urgency episodes
  • Time Frame: 4 Weeks
    Safety Issue?: No
• Percentage and absolute change in micturition frequency
  • Time Frame: 4 Weeks
    Safety Issue?: No
• Percentage and absolute change in normalized micturition frequency (NMF)
  • Time Frame: 4 Weeks
    Safety Issue?: No
• Patient perception of their urinary urgency (using the OAB-q symptom severity scale)
  • Time Frame: 4 Weeks
    Safety Issue?: No
• Patient perception of Health Related Quality of Life (using the OAB-q SF HRQL scale)
  • Time Frame: 4 Weeks
    Safety Issue?: No
• Patient Perception of Bladder Condition (PPBC) scale
  • Time Frame: 4 Weeks
    Safety Issue?: No

Inclusion Criteria:

• Women > 18 years Old
• Diagnosis of OAB (micturition frequency >/= 8 times per day; urinary urgency >/= 4 times per week)

Exclusion Criteria:

• Subjects with symptoms of overactive bladder for less than 6 months prior to randomization.
• Significant stress incontinence as determined by the investigator e.g. stress predominant mixed incontinence, positive cough provocation test.
• Subjects with any condition that would contraindicate the use of tolterodine or pregabalin, including: Uncontrolled narrow angle glaucoma; Urinary retention;
• Myasthenia gravis; Gastric retention; Severe ulcerative colitis; Toxic megacolon; Rare hereditary problems of galactose intolerance; Fructose intolerance; Sucrose-isomalate insufficiency; Lapp lactase deficiency; Glucose-galactose malabsorption.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00746681

Study ID Number: A8881001

ClinicalTrials.gov Identifier: NCT00746681

Health Authority: Norway: The National Committees for Research Ethics in Norway

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